Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure

Inclusion Criteria:

- Patient is 18 years of age or older

- Patient (or patient's legally authorized representative) is willing and able to
provide written informed consent

- Patient is willing and able to comply with the protocol, including follow-up visits

- Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial
fibrillation (i.e, palpitations)

- Patient is indicated for the Reveal XT insertable cardiac monitor or other
commercially-available and substantially equivalent Medtronic insertable cardiac
monitor

- Recent HF event within prior 120 days (HF event defined as meeting any one of the
following two criteria: 1. Admission with primary diagnosis of HF 2. Intravenous HF
therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the
following settings: admission with secondary/tertiary diagnosis of HF, emergency
department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's
home

- Willing and able to transmit data via CareLink

Exclusion Criteria:

- Patient is pregnant

- Patient has been participating in another study that may interfere with the
IDENTIFY-HF protocol required procedures

- Endstage (Stage D or New York Heart Association class IV) heart failure

- Asymptomatic (Stage B or New York Heart Association class I) heart failure

- Severe aortic stenosis or insufficiency

- Existing insertable cardiac monitor implanted for more than 1 year

- Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac
resynchronization therapy device

- Severe renal impairment (estimated glomerular filtration rate <25mL/min)

- Myocardial infarction within prior 30 days